Drugs
FDA has approved a Sanofi NDA for Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B , with or without Factor VIII or IX inhibitors (neutralizing antibodies). “Qfitlia does not
Devices
FDA has cleared a Vasorum 510(k) for the Celt ACD Plus vascular closure device, its next-generation device that it says provides physicians with a visual indicator for precise placement and closure, particularly in cases where ultrasound imaging is not available. The device is available in 5F, 6F, and
Biologics
The Autism Self-Advocacy Network (ASAN) is blasting HHS and secretary Robert F. Kennedy, Jr., for hiring “known conspiracy theorist and quack David Geier to run a planned study which will investigate the thoroughly disproven idea of a link between childhood vaccinations and autism.” In a statement, ASAN says that
Drugs
Sens. Charles Grassley (R-IA), Richard Durbin (D-IL), Thom Tillis (R-NC), Peter Welch (D-VT), and Chris Coons (D-DE) have introduced the Interagency Patent Coordination and Improvement Act to establish a task force between FDA and the U.S. Patent and Trademark Office to “improve communication and
FDA Policy/General
FDA will lose about 3,500 (18%) of its 19,000 full-time employees under a just-announced HHS restructuring in response to president Trump’s Department of Government Efficiency (DOGE) Workforce Optimization Initiative executive order. This is in addition to the 1,000 agency probationary employees who were cut
Devices
Several FDA scientists who still have positions at the agency have told Reuters anonymously that the agency is likely to miss congressionally mandated user fee review deadlines for medical devices. The news service’s exclusive report says the scientists have been told to shelve easier applications and stop providing early
Drugs
FDA has approved a Soleno Therapeutics NDA for Vykat XR (diazoxide choline) extended-release tablets for treating hyperphagia in individuals with Prader-Willi syndrome (PWS). Soleno says hyperphagia, an insatiable hunger that is common in PWS, can severely impact the lives of individuals and their caregivers. Approval was based on
Devices
The Justice Department says it has reached a settlement agreement with New Hampshire medical device manufacturer Prometheus and its owner, Richard Poore, to pay the government $550,000 to resolve False Claims Act allegations. A suit against the company and Poore alleges that they caused healthcare providers to bill Medicare
Drugs
FDA has accepted for review a Merck BLA for a subcutaneous formulation of Keytruda (pembrolizumab) for its use across all previously approved solid tumor indications. The agency has set a user fee review action target date of 9/23. The submission is based on data from Merck’s pivotal 3475A-
Drugs
FDA has approved the Fresenius Kabi BLAs for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) for all indications of the reference products, Amgen’s Prolia (denosumab) and Xgeva (denosumab) respectively. The company says it has reached a global settlement with Amgen for its denosumab biosimilars to permit
FDA Policy/General
The U.S. Senate 3/25 voted 56 to 44 to confirm the nomination of Marty Makary as the next FDA commissioner. The floor vote follows the Senate Health Education Labor and Pensions (HELP) Committee’s vote 3/13 to advance the nomination. Makary will likely be sworn in sometime
Drugs
An FDA 9/23-9/27/2024 inspection at the Yangzhou Sion Commodity Co. drug manufacturing facility in Yangzhou, Jiangsu, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/12 Warning Letter says the specific violations were: * failure to test samples of each
FDA Policy/General
AstraZeneca says new study data on Tagrisso (osimertinib) show an “improved overall survival trend” in patients with epidermal growth factor receptor-mutated non-small cell lung cancer. Results from the Phase 3 LAURA trial demonstrated that patients on Tagrisso lived a median 58.8 months compared with 54.1 months
Devices
A 10/17-1/24/2024 FDA inspection at Exer Labs in Denver, CO, determined that the firm is illegally marketing its Exer Scan. A just-released 2/10 Warning Letter says the firm does not have an approved PMA or IDE application for its device and also did not
Devices
FDA has updated with 2024 information the Web page it maintains on issues with the withdrawn Bayer Essure implanted birth control device. FDA says it received 803 medical device reports on Essure in 2024, significantly lower than the 3,626 reports received in 2023. It was the lowest number of
Drugs
The Washington-based law firm of Buchanan Ingersoll & Rooney is asking FDA to continue restrictions on ANDAs citing Waylis’ Tabloid (thioguanine) as the reference-listed drug. The 3/24 petition asks the agency to: * maintain and strictly apply the requirements of the current product-specific guidance (PSG) to any
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says its review of the “Efficacy Results” Web page for Taiho Oncology’s Lytgobi (futibatinib) tablets found it makes false and misleading representations about the drug’s benefits. A 3/21 Notice of Violation says the violations are particularly concerning because the
Devices
FDA has issued Nyxoah an approvable letter on its PMA for the Genio system, a neuromodulation device for treating obstructive sleep apnea (OSA). The agency letter said the device could be approved once issues with the company’s manufacturing facilities, methods and controls are satisfactorily addressed and reviewed. “The FDA
Biologics
Johnson & Johnson says data from its Phase 3 MARIPOSA study, a head-to-head study comparing the company’s Rybrevant (amivantamab-vmjw) versus AstraZeneca’s Tagrisso (osimertinib), showed that Rybrevant plus Janssen’s Lazcluze (lazertinib) outperformed Tagrisso by a three-to-one margin, significantly extending overall survival (OS) in
Devices
Covidien has recalled (Class 1) its Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula due to safety concerns about a component potentially becoming disconnected. The device has a flange that “may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue
Devices
A 10/21-11/7/2024 FDA inspection at Dexcom in San Diego, CA, and a 6/10-6/14/2024 inspection at the firm’s facility in Mesa, AZ, found seven Quality System Regulation violations in its manufacturing of G6 and G7 continuous glucose monitors. A just-released 3/
Drugs
A 9/16-9/21/2024 FDA inspection at the Aspen Biopharma Labs Private Limited drug manufacturing facility in Hyderabad, Telangana, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 3/5 Warning Letter says the specific deviations were: * failure